Friday, June 29, 2018

Lannett Holdings loses appeal in zolmitriptan case

Appellant Lannett Holdings lost at the CAFC:

Lannett Holdings Inc. and Lannett Co. Inc. (together,
“Lannett”) appeal from the decision of the United States
District Court for the District of Delaware concluding,
after a bench trial, that claims 4, 11, 12, and 14 of U.S.
Patent 6,760,237 (“the ’237 patent”) and claims 6 and 14–
16 of U.S. Patent 7,220,767 (“the ’767 patent”) were not
shown to be invalid, see Impax Labs., Inc. v. Lannett
Holdings Inc., 246 F. Supp. 3d 1024 (D. Del. 2017) (“Opinion”),
entering judgment in favor of Impax Laboratories
Inc. (“Impax”), AstraZeneca AB, and AstraZeneca UK
Limited (together, “AstraZeneca”), and entering an injunction
against Lannett pursuant to 35 U.S.C.
§ 271(e)(4), see Impax Labs. Inc. v. Lannett Holdings Inc.,
No. 1:14-cv-00984-RGA (D. Del. Apr. 17, 2017), ECF No.
174; J.A. 1–4. For the reasons that follow, we affirm.

The issue was obviousness:

We proceed to the obviousness issue, the sole issue on
appeal, based on the prior art references and arguments
properly before us. On appeal from a bench trial, we
review a district court’s conclusions of law de novo and its
findings of fact for clear error. Golden Blount, Inc. v.
Robert H. Peterson Co., 365 F.3d 1054, 1058 (Fed. Cir.
2004). A factual finding is only clearly erroneous if,
despite some supporting evidence, we are left with the
definite and firm conviction that a mistake has been
made. United States v. U.S. Gypsum Co., 333 U.S. 364,
395 (1948); see also Polaroid Corp. v. Eastman Kodak Co.,
789 F.2d 1556, 1559 (Fed. Cir. 1986) (“The burden of
overcoming the district court’s factual findings is, as it
should be, a heavy one.”).

A party challenging the validity of a patent must establish
invalidity by clear and convincing evidence. See
Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91, 95 (2011).
Clear and convincing evidence should “place[] in the fact
finder ‘an abiding conviction that the truth of [the] factual
contentions are highly probable.’” Procter & Gamble Co.
v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed. Cir.
2009) (quoting Colorado v. New Mexico, 467 U.S. 310, 316
(1984)) (second alteration in original).

Of note:

Contrary to Lannett’s contentions, the district court
found that zolmitriptan’s more potent, active metabolite
was actually thought to be significant for its efficacy by a
person of skill in the art at the time. Specifically, the
court credited Appellees’ evidence of expert testimony and
studies and found that a skilled artisan would have
expected delayed or lower therapeutic effectiveness from
zolmitriptan if administered nasally because it would
have been “absolutely counterintuitive to make a nasal
spray when you have an active metabolite which is more
potent . . . than the drug itself.” Opinion, 246 F. Supp. 3d
at 1037 (quoting Dr. Rapoport); J.A. 667. As such, the
court found that “because of zolmitriptan’s reliance on its
active metabolite, the prior art failed to teach that
zolmitriptan by itself would be effective.” Id. The court
thus found zolmitriptan’s acting through its metabolite
not only relevant, which was substantially undisputed,
but also significant for a skilled artisan to consider regarding
whether to make intranasally administered


Based on the record before us, we do not find that the
court clearly erred in concluding that at the time,
zolmitriptan’s known significant reliance on its active
metabolite would have, on balance, dissuaded a person of
skill in the art from making nasal formulations of
zolmitriptan. See, e.g., Winner Int’l Royalty Corp. v.
Wang, 202 F.3d 1340, 1349–50 (Fed. Cir. 2000) (no clear
error in the district court’s finding that a person of skill in
the art, on balance, would not have made the claimed
invention); Intendis GmbH v. Glenmark Pharm. Inc., 822
F.3d 1355, 1366–67 (Fed. Cir. 2016) (no clear error when
the district court found that a person of skill in the art
would have pursued other formulations).


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